MAUDE Adverse Event Report: ESTABLISHMENT LABS S.A. MOTIVA SILKSURFACE PLUS WITH QID; MOTIVA IMPLANTS

Catalog Number	RSF-355+Q
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Impaired Healing (2378)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
"a number of risk factors for rupture have been identified; the most common cause is surgical instrument damage.¿ (handel, garcía and winxtrom, 2013.Breast implant rupture: causes, incidence, clinical impact, and management.Plast.Reconstr.Surg.132: 1128.).Breast implants are not considered lifetime devices, and implant rupture is a risk associated with breast surgery, which can occur at any time.The origin of infection in women with implants remains difficult to determine, but potential sources include a contaminated implant, the surgery itself or the surgical environment, the patient's skin or mammary ducts, or, as suggested by many reports, seeding of the implant from remote infection sites.(pittet et al, 2005).Extrusion represents potential complications associated with the use of breast implants, it involves the implant coming through the skin, normally through the incision where it¿s been placed.Extrusion can happen for several reasons, such as the skin over the implant thinned too much leaving too little coverage for the implant, the implant used is too large, the incision did not heal well and broke open.Implant exposure due to poor tissue coverage frequently obligates the surgeon to remove the breast implant and begin anew (gargano, ciminello & de santis; 2009).Additionally, these conditions are common and known reasons for complaints, and they are clearly characterized in the product dfu included with the implant, as stated above.Additionally, no cases of rupture because of product failure have been reported to establishment labs ever.The instructions for use in the directions for use were reviewed to determine if there are indications that ensure the prevention and good handling of the product.For this event, it is considered that the information is suitable on the section of surgical precautions as follows: ¿breast implants can potentially remain intact for decades in the body, but all such devices will fail at some point.Breast implants rupture when the shell develops a tear or hole.Rupture can occur at any time after implantation, but it is most likely to occur; the longer the implant is in place.The following may cause implants to rupture: damage by surgical instruments, implant stress, and weakening during implantation, age and design of the implant, submuscular rather than sub-glandular location, the occurrence of post-operatory hematomas or seromas, folding or wrinkling of the implant shell, excessive force to the chest, trauma, compression during mammographic imaging, and severe capsular contracture¿.¿infection can occur with any surgery or implant.Most infections resulting from surgery appear within a few days to weeks after the operation.However, infection is possible at any time after surgery.In addition, breast and nipple piercing procedures may increase the possibility of infection.Infections in tissue with an implant present are harder to treat than infections in tissue without an implant.If an infection does not respond to antibiotics, the implant may have to be removed, and another implant may be placed after the infection is resolved"."breast implant extrusion, or breast implant exposure, occurs when the breast skin and tissues that are holding the implant fail, causing the implant to protrude through the skin and become exposed.It happens in less than 2% of patients; it is shortly after breast augmentation or down the road.Breast-implant extrusion can occur for various reasons, such as improper wound healing due to an infection, trauma, too little soft-tissue coverage, oversized implant coupled with too little tissue coverage, or lack of blood supply.Breast-implant extrusion calls for surgery and removal of the implant".Also, a complete review of the dhr's was carried out, no deviation was found in the process, so it is established that there is no evidence of a relationship between the event and the manufacturing process.No device return confirmation has been received so far.
Event or Problem Description
Argentina.It was reported that a patient operated on in (b)(6) 2024, presented an extrusion and infection in the right implant in (b)(6) 2025.A revision surgery was performed and the implant was found with a rupture.No patient demographics, such as age, weight, or ethnicity, were provided by the reporter, and no adverse outcomes for the patient have been noted.Efforts to gather additional information are ongoing, and the investigation remains in progress.
Additional Manufacturer Narrative
Quality department (pms) has received a complaint regarding a device from establishment labs.General conclusion: a relationship between the alleged event and the device involved: yes.Event analysis: device rupture.Tests were performed according to ¿(b)(4) pms laboratory testing units¿: the visual inspection of the unit found a device rupture.Microscope inspection showed trace marks in the shell consistent with those of a sharp instrument reproduced in our laboratory, this is distinct from the pattern resulting from a spontaneous tear in the shell of the implant.Tests performed confirmed the shell complied with the international specification standards.Test results: in conclusion, it was determined that a probable cause for the event reported was a cut resulting from a sharp instrument used which could have weakened the shell.Additionally, rupture is a common and known reason for complaints, and it is clearly characterized in the product dfu included with the implant, as stated above.Breast implants are not considered lifetime devices, and implant rupture is a risk associated with breast surgery, which can occur at any time.Extrusion: after an analysis of the clinical evidence provided and the report, it was possible to confirm the alleged event.The alleged event is a risk associated with breast surgery and there is no evidence to suggest a link between this particular implant and/or its manufacturing process and a higher risk of occurrence.The cause of this event is multifactorial, and we cannot conclude that the reported event was caused by the manufacturing process and/or the product itself.Infection: after an analysis of the clinical evidence provided and the report, it was possible to confirm the alleged event.The alleged event is a risk associated with breast surgery and there is no evidence to suggest a link between this particular implant and/or its manufacturing process and a higher risk of occurrence.The cause of this event is multifactorial, and we cannot conclude that the reported event was caused by the manufacturing process and/or the product itself.Dhr review: a complete review of the dhr for lot involved was carried out, no deviation was found in the manufacturing process.Additionally, there were no indications of abnormalities in raw materials or manufacturing processes which may have affected this particular batch.Test results: in conclusion, it was determined that a probable cause for the event reported was a cut resulting from a sharp instrument used which could have weakened the shell.Additionally, rupture is a common and known reason for complaints, and it is clearly characterized in the product dfu included with the implant, as stated above.Breast implants are not considered lifetime devices, and implant rupture is a risk associated with breast surgery, which can occur at any time.Establishment labs will continue to monitor for similar complaints/trends.As part of the post market surveillance process, monitoring of the primary endpoints reported is performed to determine unfavorable trends.Per our current complaint data report, no unfavorable trends were detected on this product.No further actions are required.

• Brand Name: MOTIVA SILKSURFACE PLUS WITH QID
• Common Device Name: MOTIVA IMPLANTS
• Manufacturer (Section D): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela
• Manufacturer (Section G): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela ; 8003554164
• MDR Report Key: 21935779
• Report Number: 3012883202-2025-00630
• Device Sequence Number: 7893095
• Product Code: FTR
• UDI-Device Identifier: 07445161002907
• UDI-Public: (01)07445161002907(11)230831(17)280831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RSF-355+Q
• Device Lot Number: 23082718
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown